G/TBT/N/TPKM/520  
22 March 2023  
(23-2056) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, 
KINMEN AND MATSU  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Food and Drug Administration, Ministry of Health and Welfare  
No.161 -2, Kunyang St, Nangang District, Taipei City 115209, Taiwan  
TEL : 886 -2-2787-7523 
E-mail: f707450@fda.gov.tw  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
device: Medical Equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Amendments to Article 7 and to the Annex to Article 4 of the "Regulations Governing the 
Classification of  Medical Devices"; (43 page(s), in English), (27 page(s), in Chinese)  
6. Description of content:  As medical devices involve a variety of scientific fields, their 
types, items, and compositions are complex and rapidly changing. To clarify the scope of 
medical devices subject to management, we have reviewed the contents of the Annex to 
Article 4 of the "Regulations Governing the Classification of Medical Devices" and made 
appropriate revisions based on international management approaches and the current 
situation. It is recognized that medical device firms should be given a grace period to 
respond to the amendments, and Article 7 has been amended accordingly. The proposed 
amendments are as follows: (1) The date of entering into force for the new product items  
in Article 4. (Amendment to Article 7); (2) 64 product items have been added. 
(Amendment to the Annex to Article 4)  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Harmonization  
8. Relevant documents:   
Medical Devices Act  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/TPKM/520  
 
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  10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT Enquiry Point  
Bureau of Standards, Metrology and Inspection  
Ministry of Economic Affairs  
No. 4, Sec. 1, Jinan Rd., Zhongzheng Dist.  
Taipei City 1 00, Taiwan  
Tel: +(886 -2) 23431916  
Fax: +(886 -2) 23431804  
Email: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattach ments/2023/TBT/TPKM/23_2138_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/TPKM/23_2138_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/TPKM/23_2138_00_x.pdf  
https://members.wto.org/crnattachments/20 23/TBT/TPKM/23_2138_01_x.pdf